Mohammed Yaseen
Regulatory Affairs (Cmc) Writer @Sanofi
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WORK HISTORY
Regulatory Affairs (Cmc) Writer @Sanofi
Hyderabad, IN
Technical Writing, Combination Products, Medical Devices, Regulatory Affairs, EU MDR, FDA, Design control
EDUCATION
CARE School of Engineering
Bachelor of Engineering - BE
ABOUT MOHAMMED YASEEN
MedTech Professional with comprehensive experience in EU MDR 2017/745 compliance, medical device technical file remediation, and notified body submissions. Skilled in managing notified body responses and aligning documentation with both MDR and legacy MDD requirements. Proficient in preparing Risk Management Files in accordance with ISO 14971, and experienced in clinical and post-market documentation including CERs, PMSR/PSUR, and SSCPs. Strong command over technical documentation and design control processes, with a proven track record in creating, reviewing, and approving regulatory and engineering deliverables. Well-versed in key international standards such as ISO 13485, ISO 14971, ISO 20417, ISO 15223-1, and the ISO 10993 biocompatibility series. Demonstrated expertise in authoring Design Verification Protocols and Test Reports for medical devices to ensure compliance with regulatory and product-specific standards. In addition to regulatory proficiency, I bring hands-on skills in design software tools including SolidWorks, Adobe Illustrator, and Adobe InDesign, supporting high-quality documentation and product design communication. Open to global opportunities in regulatory affairs, quality, and compliance roles within the medical device industry.
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